Efficacy of ankle-foot orthoses on walking ability in peripheral artery disease

Abstract

Calf claudication is a significant cause of walking limitation for patients with peripheral artery disease (PAD). Ankle-foot orthoses (AFO) are leg devices that can reduce the physical demands on the calf muscles during ambulation. The purpose of this study was to determine the efficacy of AFO on walking ability in patients with PAD. This was an open-label, interventional trial including 15 patients with calf claudication who were fit with AFO. Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum. Comparison of peak walking time (PWT) at baseline versus 12 weeks was the primary outcome. A secondary outcome was claudication onset time (COT) assessed during graded treadmill tests. Change in walking ability of AFO group patients was also compared to outcomes from a historical PAD control group ( n = 10) who received upfront advice to walk at home. Patients in the AFO group significantly improved their walking ability from baseline to 12 weeks (mean ± SD) (PWT: 7.8 ± 5.1 to 9.3 ± 5.4 min, p = 0.049; COT: 3.0 ± 2.3 to 4.8 ± 2.7 min, p = 0.01). Change in PWT for AFO group patients when tested without using the devices was not significantly greater compared to historical controls (+1.4 ± 2.4 vs +0.1 ± 2.6 min, p = 0.16) but it was for COT (+1.8 ± 2.5 vs −0.6 ± 2.2 min, p = 0.02). This study found that AFO used during community-based walking improved the primary outcome of PWT in patients with PAD. Further, using AFO delayed claudication onset, indicating patients may be able to increase their walking activity. Large-scale, randomized controlled trials are needed to further explore the use of AFO for PAD. ClinicalTrials.gov identifier: NCT02280200.

Assessing wear time and perceptions of wearing an ankle foot orthosis in patients with peripheral artery disease

“…4,5 Contrary to our findings, a study by Mays and colleagues (2019), who examined the effect of the Ottobock WalkOn Reaction AFO during an unstructured communitybased walking program, found that participants with PAD had self-reported improvements in their ability to walk up and down stairs after using an AFO for 12 weeks. 16 Discomfort in general and challenges while driving were other important barriers reported by participants in our study, and others, that could greatly limit participant wear time of the AFO. 17 Efforts are needed to address driving barriers to improve adherence to wearing the AFO by participants with PAD.…”

“…Similar to other research of individuals wearing an AFO and specifically people with PAD, participants reported that they could walk farther and most often saw these differences while doing daily activities. 16,17,29 The study by Mays and colleagues also found that participants with PAD who wore an AFO perceived improvements in their overall quality of life. 16 Other research has found the most sought after features of AFOs related to effectiveness, reliability, durability, and comfort as well as ensuring that the AFO can help improve walking and standing.…”

“…16,17,29 The study by Mays and colleagues also found that participants with PAD who wore an AFO perceived improvements in their overall quality of life. 16 Other research has found the most sought after features of AFOs related to effectiveness, reliability, durability, and comfort as well as ensuring that the AFO can help improve walking and standing. 11,29 In addition, participants relied on the devices to enable them to pursue daily activities such as job duties, driving, outdoor activities, and social events.…”

“…14 However, a majority of these studies were based on participant self-report questionnaires or interviews. 16 Additional research is needed to objectively examine wear time of AFOs and other orthotic devices.…”

“…14 Previous work examining the use of an AFO in participants with PAD has found that participants significantly increased their peak walking time and delayed the onset of claudication. 16 In a qualitative study exploring participants' perceptions, participants believed that the AFO improved their ability to walk and their quality of life, particularly when used on flat surfaces. 17 However, they did experience barriers to wear such as walking on uneven ground, driving, and existing lower extremity conditions.…”